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Aptahem on schedule for clinical studies

Aptahem on schedule for clinical studies

31 August, 2022

Malmö-based biotech Aptahem, which is developing the drug candidate Apta-1 as a new type of emergency treatment for sepsis, released its Q2 report last week. It is clear that the company, which is approaching the first in-human studies, is so far on schedule and that more and more details are falling into place for the upcoming clinical work.

Aptahem’s goal with the development of the drug candidate Apta-1 is to get more patients to survive sepsis and septic shock, but also that the treatment should counteract any permanent damage that may occur because of this condition. Every year, 50 million people are affected, of which 11 million die, making sepsis one of the most serious threats to global public health.

If treatment is not initiated quickly upon onset, even everyday infections, which reach the bloodstream via, for example, wounds, can lead to life-threatening organ failure. When sepsis is treated with antibiotics, there is a risk that the patient will suffer from antibiotic resistance, which means that there is a great need for new medical solutions.

Progress in Q2

On August 25, Aptahem published its Q2 report for 2022. As Apta-1 is still in the development phase and no drugs have yet been commercialised, the company reported no sales, as expected. At the end of the quarter, however, the company strengthened its cash position through the exercise of series TO7 warrants, which were exercised to 92 percent. The warrants added 8.6 MSEK to the coffers after capital raising costs, which means that the company now has a cash runway amounting to 23.9 MSEK.

Participation in consortium

In May, Aptahem joined a new consortium together with Örebro University, Attgeno, BioReperia, Buzzard Pharmaceuticals, Lipum, Thermo Fisher Scientific and Toleranzia. The joint research project Drug discovery targeting inflammation – novel therapeutic aspects on vascular inflammation, thrombosis and breast cancer, has received funding from KK-stiftelsen, whose mission is to strengthen Sweden’s competitive edge through funding of scientific research. The project will run over four years starting at the end of 2022.

Aptahem will primarily provide the project with its drug candidate Apta-1, as well as contribute with expertise from DrLuiza Jedlina, Aptahem´s CSO and co-founder, as scientific advisor regarding aptamer-based drugs and especially for Apta-1’s inhibition of inflammation and thrombosis. Aptahem’s CEO Mikael Lindstam was also part of the steering group that was able to represent the consortium’s application to KK-stiftelsen.

New agreement with CRO

An important step towards the upcoming clinical studies is to appoint a clinical contract research organisation (CRO) and on May 17, the company signed an agreement with The Centre for Human Drug Research (CHDR) in the Netherlands for the implementation of the phase I studies with Apta-1. According to Aptahem, the agreement is an important part of being able to continue the study planning and preparation work for the application to the authorities, a work that has been ongoing during the summer.

Another piece of the puzzle also fell into place for Aptahem during the quarter when, on June 1, the company appointed Ingela Hallberg as new Chief Medical Officer (CMO). Hallberg has a long experience of taking pharmaceutical projects through the various clinical development stages. Read BioStock’s interview with Hallberg here. The company strengthened the organisation further by the election of Åsa Kornfeld and Jan Nilsson as new members of the Board.

Report from GLP studies completed

During the reporting period, Aptahem also completed a final study report from the GLP-regulated (Good Laboratory Practice) toxicology and safety studies. The report confirms what the company has previously communicated, i.e., that the drug candidate Apta-1 shows good safety and is very well tolerated within the dose window. The GLP toxicology studies are the last part of the mandatory preclinical program to be able to take Apta-1 further to clinical phase. The fact that these have been implemented in accordance with GLP means that they have complied with government-regulated requirements.

In 2022, they also received a first delivery of the completed GMP (Good Manufacturing Practice) batch of Apta-1, which has also been carried out in accordance with current regulatory requirements. Recipharm is now developing Apta-1 into the final investigational medicinal product that will be used in the upcoming clinical studies.

Strengthened IP portfolio

During the summer, the company’s patent family 2 was also approved in Europe after a period of potential opposition. Aptahem has thus strengthened its IP portfolio with increased patent protection for the patent family in this region. All in all, Aptahem looks to be well prepared for the upcoming clinical studies. So far, the company is following its set timetable, which in itself can be a challenge in the biotech area, with all its carefully stipulated and high regulatory requirements.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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